Laparoscopically assisted versus open oesophagectomy for patients with oesophageal cancer-the Randomised Oesophagectomy: Minimally Invasive or Open (ROMIO) study: protocol for a randomised controlled trial (RCT)

Rachel C Brierley, Daisy Gaunt, Chris Metcalfe, Jane M Blazeby, Natalie S Blencowe, Marcus Jepson, Richard G Berrisford, Kerry N L Avery, William Hollingworth, Caoimhe T Rice, Aida Moure-Fernandez, Newton Wong, Joanna Nicklin, Anni Skilton, Alex Boddy, James P Byrne, Tim Underwood, Ravi Vohra, James A Catton, Kish Pursnani, Rachel Melhado, Bilal Alkhaffaf, Richard Krysztopik, Peter Lamb, Lucy Culliford, Chris Rogers, Benjamin Howes, Katy Chalmers, Sian Cousins, Jackie Elliott, Jenny Donovan, Rachael Heys, Robin A Wickens, Paul Wilkerson, Andrew Hollowood, Christopher Streets, Dan Titcomb, Martyn Lee Humphreys, Tim Wheatley, Grant Sanders, Arun Ariyarathenam, Jamie Kelly, Fergus Noble, Graeme Couper, Richard J E Skipworth, Chris Deans, Sukhbir Ubhi, Robert Williams, David Bowrey, David Exon, Paul Turner, Vinutha Daya Shetty, Ram Chaparala, Khurshid Akhtar, Naheed Farooq, Simon L Parsons, Neil T Welch, Rebecca J Houlihan, Joanne Smith, Rachel Schranz, Nicola Rea, Jill Cooke, Alexandra Williams, Carolyn Hindmarsh, Sally Maitland, Lucy Howie, Christopher Paul Barham, Rachel C Brierley, Daisy Gaunt, Chris Metcalfe, Jane M Blazeby, Natalie S Blencowe, Marcus Jepson, Richard G Berrisford, Kerry N L Avery, William Hollingworth, Caoimhe T Rice, Aida Moure-Fernandez, Newton Wong, Joanna Nicklin, Anni Skilton, Alex Boddy, James P Byrne, Tim Underwood, Ravi Vohra, James A Catton, Kish Pursnani, Rachel Melhado, Bilal Alkhaffaf, Richard Krysztopik, Peter Lamb, Lucy Culliford, Chris Rogers, Benjamin Howes, Katy Chalmers, Sian Cousins, Jackie Elliott, Jenny Donovan, Rachael Heys, Robin A Wickens, Paul Wilkerson, Andrew Hollowood, Christopher Streets, Dan Titcomb, Martyn Lee Humphreys, Tim Wheatley, Grant Sanders, Arun Ariyarathenam, Jamie Kelly, Fergus Noble, Graeme Couper, Richard J E Skipworth, Chris Deans, Sukhbir Ubhi, Robert Williams, David Bowrey, David Exon, Paul Turner, Vinutha Daya Shetty, Ram Chaparala, Khurshid Akhtar, Naheed Farooq, Simon L Parsons, Neil T Welch, Rebecca J Houlihan, Joanne Smith, Rachel Schranz, Nicola Rea, Jill Cooke, Alexandra Williams, Carolyn Hindmarsh, Sally Maitland, Lucy Howie, Christopher Paul Barham

Abstract

Introduction: Surgery (oesophagectomy), with neoadjuvant chemo(radio)therapy, is the main curative treatment for patients with oesophageal cancer. Several surgical approaches can be used to remove an oesophageal tumour. The Ivor Lewis (two-phase procedure) is usually used in the UK. This can be performed as an open oesophagectomy (OO), a laparoscopically assisted oesophagectomy (LAO) or a totally minimally invasive oesophagectomy (TMIO). All three are performed in the National Health Service, with LAO and OO the most common. However, there is limited evidence about which surgical approach is best for patients in terms of survival and postoperative health-related quality of life.

Methods and analysis: We will undertake a UK multicentre randomised controlled trial to compare LAO with OO in adult patients with oesophageal cancer. The primary outcome is patient-reported physical function at 3 and 6 weeks postoperatively and 3 months after randomisation. Secondary outcomes include: postoperative complications, survival, disease recurrence, other measures of quality of life, spirometry, success of patient blinding and quality assurance measures. A cost-effectiveness analysis will be performed comparing LAO with OO. We will embed a randomised substudy to evaluate the safety and evolution of the TMIO procedure and a qualitative recruitment intervention to optimise patient recruitment. We will analyse the primary outcome using a multi-level regression model. Patients will be monitored for up to 3 years after their surgery.

Ethics and dissemination: This study received ethical approval from the South-West Franchay Research Ethics Committee. We will submit the results for publication in a peer-reviewed journal.

Trial registration number: ISRCTN10386621.

Keywords: minimally invasive oesophagectomy; oesophageal cancer; oesophagectomy; quality of life; randomised controlled trial.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
Consort diagram outline. MDT, multidisciplinary team; PIL, patient information leaflet; TMIO, totally minimally invasive oesophagectomy; LAO, laparoscopically assisted oesophagectomy; OO, open oesophagectomy.
Figure 2
Figure 2
Diagrams representing the incisions the surgeon may make for the three different surgical approaches.

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